Kornimate/medical-research-clean huggingface dataset:
epidemiology study of non-arteritic anterior ischemic optic neuropathy (naion)

Conditions: Anterior Ischemic Optic Neuropathy; Ischemic Optic Neuropathy

Summary: the objectives of this study were to: (1) evaluate the natural history of non-arteritic anterior ischemic optic neuropathy (naion); (2) estimate the population incidence of naion; and (3) identify potential risk factors for naion.

the study population consisted of members of the ingenix normative health informatics (nhi) database during 01/01/2003 through 12/31/2007, who were 18 years of age or older with at least 183 days of continuous enrollment in the database and without any doctor visits associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry. from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential naion cases (n = 3,732). from the potential naion cases, definite and possible naion cases were identified using medical record review and a claims algorithm (n=1,283). from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)

Eligibility criteria:
inclusion criteria: * member of the ingenix normative health informatics (nhi) database during 01/01/2003 through 12/31/2007 * 18 years of age or older * had at least 183 days of continuous enrollment in the database * no doctor visits associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry exclusion criteria: * less than 18 years of age * less than 183 days of continuous enrollment in the database * at least one doctor visit associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry

Keywords: phosphodiesterase type 5 inhibitors non-arteritic anterior ischemic optic neuropathy descriptive epidemiology study
a study of brivanib (bms-582664) in patients with liver cancer and mild, moderate or severe liver dysfunction

Conditions: Carcinoma, Hepatocellular

Summary: the primary purpose of this protocol is to determine the effect of bms-582664 on patients with hepatocellular carcinoma with varying levels of hepatic impairment


Eligibility criteria:
inclusion criteria: * subjects with a biopsy proven advanced solid tumor * subjects with a biopsy proven diagnosis of hepatocellular carcinoma conforming to child pugh classifications a, b, or c

Keywords: hepatocellular cancer other advanced solid malignancies
bioinformation therapy for breast cancer

Conditions: Advanced Breast Cancer

Summary: the aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable breast cancer.

by enrolling patients with unresectable breast cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies * body tumor 1-6, with at least one tumor length \> 2 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: cancer ablation life information rehabilitation therapy
bioequivalence between nicotine replacement products and nicorette® gum

Conditions: Tobacco Dependence

Summary: bioequivalence between oral nicotine replacement products and nicorette® gum.

this study compares a new oral nicotine replacement therapy (nrt) product containing 2 and 4 mg nicotine with nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. the study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. subjects and study personnel will be aware of which treatment is administered at a given visit.

Eligibility criteria:
inclusion criteria: * healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion and bmi between 17.5 and 30.0 kg/m2. * female participants of child-bearing potential are required to use a medically acceptable means of birth control. * a personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. exclusion criteria: * pregnancy, lactation or intended pregnancy. * treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Keywords: smoking cessation nicotine pharmacokinetics
exparel infiltrated into the tap for postoperative analgesia in unilateral abdominal hernia repair

Conditions: Hernia

Summary: phase 4 study evaluating the effectiveness of exparel when infiltrated into the the transversus abdominis plane (tap).

this is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg exparel to infiltrate into the tap unilaterally.

Eligibility criteria:
inclusion criteria: * males and females, aged 18-75 years inclusive, and asa physical status 1-3. * undergoing open repair of a unilateral abdominal hernia below the level of the umbilicus. * abdominal incision length of 3-12 cm. * subjects must be physically and mentally able to participate in the study and complete all study assessments. * subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the tap infiltration. exclusion criteria: * history of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics * any subject whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful performance of a tap infiltration. * any subject who in the opinion of the investigator, might be harmed or be a poor candidate for participation in the study. * any subject, who in the opinion of the investigator, is on chronic pain medicine. * any female subject who is currently pregnant. * subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

Keywords: analgesia hernia repair
safety and efficacy of bimatoprost/timolol (ganfort®) ophthalmic solution in korea

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this study is a post-marketing surveillance study to evaluate the safety and efficacy of bimatoprost/timolol (ganfort®) ophthalmic solution to treat open-angle glaucoma or ocular hypertension in korea.


Eligibility criteria:
inclusion criteria: * patients treated with ganfort® for open-angle glaucoma or ocular hypertension in clinical practice. exclusion criteria: * none.
study evaluating preference, satisfaction and correct use of inhalers in copd patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with copd


Eligibility criteria:
key inclusion criteria: 1. male and female adults aged ≥40 years, who have signed an informed consent form prior to initiation of any study-related procedure. 2. co-operative outpatients with a diagnosis of moderate copd as classified by the gold guidelines 2010 or grade a in gold 2011and including: * smoking history of at least 10 pack years * fev1/fvc \< 70% key exclusion criteria: 1. previous diagnosis of asthma 2. pregnant or nursing women 3. hospitalization or emergency room attendance due to copd exacerbation within 3 months prior to visit 1

Keywords: breezhaler respimat indacaterol tiotropium
the toronto prehospital hypertonic resuscitation head injury and multi organ dysfunction trial (tophr hit)

Conditions: Traumatic Brain Injury

Summary: the tophr hit trial is a clinical trial of patients experiencing blunt trauma who present with an injury to their head which makes them unconscios. the study compares two different fluids given to the patient in the out of hospital setting by a paramedic. the two fluids are salt water (standard treatment) versus a higher concentration of salt water mixed with a sugar (study fluid). the patients have an equal chance of receiving either fluid and the paramedic and the patient and the treating trauma surgeon do not know which fluid was provided in the out of hospital setting.

study objective the primary objective of this study is to report feasibility in accordance with the methodology described by lancaster and dodds, specifically addressing: 1. baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial. 2. randomization compliance rate. 3. ease of protocol implementation in the out-of-hospital setting. 4. adverse rate of hypertonic saline dextran (hsd) infusion. the secondary objectives include measuring the effect of hsd in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to hsd intervention; evaluating effects of hsd on brain atrophy post-injury and neurocognitive and neuropsychological outcomes.

Eligibility criteria:
inclusion criteria: * age ≥16 * initial assessment of glasgow coma score (gcs) 8 or less * blunt traumatic mechanism of injury exclusion criteria: * known pregnancy * penetrating primary injury * vsa prior to randomization; previous intravenous therapy ≥ 50 ml * time interval between arrival at scene and intravenous access exceeds four hours * amputation of above wrist or ankle * any burn (thermal, chemical, electrical, radiation) * suspected hypothermia * asphyxia (strangulation, hanging, choking, suffocation, drowning) and fall from height ≤ 1m or ≤ 5 stairs.

Keywords: resuscitation
swiss cardiac amyloidosis registry (swiss-care)

Conditions: Amyloid Cardiomyopathy

Summary: cardiac transthyretin amyloidosis (attr), caused by ventricular depositions of misfolded transthyretin, results in an infiltrative cardiomyopathy, progressing from pronounced myocardial wall thickening, diastolic and systolic dysfunction to the development of terminal heart failure. recently, treatment options for ttr amyloidosis have become available. however costs for therapy are enormous and previous trials were not able to differentiate between patients that might benefit from treatment and those without a need for treatment. the investigators study aims to determine markers, as assessed by cardiac magnet resonance imaging (cmr) feature tracking (ft) and t1- and t2- mapping, that might reliably indicate disease severity and could help to identify patients that might benefit from (ongoing) ttr stabilization treatment.

cardiac transthyretin amyloidosis (attr), the most common amyloidosis form with cardiac involvement, is caused by tissue deposition of misfolded ttr, a transport protein for thyroxine and retinol. ventricular depositions of amyloid fibrils results in an infiltrative cardiomyopathy, progressing from pronounced myocardial wall thickening, to diastolic and systolic dysfunction and finally chronic heart failure. while treatment options are now available, it remains unclear how to monitor therapy response and disease progression. no makers have been identified that predict outcome prior to initiation of therapy, thus patient selection for therapy remains challenging. the investigators study will address these issues and will provide systematically assessed cmr data before and over the course of 18 months after therapy initiation. clinical and laboratory follow-up will be performed every 3-6 months. the investigators study is based on an open, uncontrolled, structured collection of retrospective and prospective data from all patients diagnosed with amyloidosis at the inselspital bern with the aim to follow patients undergoing therapy. the investigators hypothesize that cmr feature tracking (ft) and measures of t1- and t2- mapping, such as extracellular volume (ecv) may better correlate with disease severity and help to identify patients likely to benefit from (ongoing) ttr stabilizing therapy. beside standard cmr assessments, the investigators will use cmr feature tracking to quantify global and regional myocardial function. ft has proven to be an excellent predictor in various cardiomyopathies. the proposed study will evaluate the potential of cmr to identify patients likely to benefit from therapy, monitor treatment response and balance individual patient benefit and health care cost.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of amyloidosis w/wo cardiac involvement * general consent exclusion criteria: * inability to give consent or existence of a written or documented oral refusal of the data subject.\<18 years of age

Keywords: cardiac amyloidosis tafamidis cmr feature tracking strain t1 and t2 mapping outcomes
respiratory functions in pediatric-onset multiple sclerosis

Conditions: Pediatric-onset Multiple Sclerosis

Summary: pediatric-onset multiple sclerosis (poms) is a chronic, autoimmune and inflammatory disease of the central nervous system that begins before the age of 18 years. poms patients are affected in terms of physical capacity, cognitive status and fatigue compared with their healthy peers that has been reported. it has been reported that although individuals with ms with low disability levels do not have respiratory complaints, respiratory parameters may be affected. therefore, it is necessary to evaluate respiratory capacity, respiratory muscle strength and fatigue levels of poms patients. evaluations will help prevent future complications by detecting any existing problems early.

people with pediatric onset multiple sclerosis (poms) may experience sensory, motor, cerebellar and cognitive dysfunctions due to the destruction of the central nervous system. these disorders can cause decrease in physical capacity, increase in cognitive symptoms and fatigue level in patients with poms. there is no study in the literature examining the relationship between respiratory capacity and respiratory muscle strength with fatigue in poms patients. the aim of this study is to compare poms patients and healthy controls in terms of respiratory capacity, respiratory muscle strength and fatigue. all participants's respiratory function will be evaluated with "minispir light spirometer", respiratory muscle strength with "md diagnostics rp check" and fatigue with pediatric quality of life inventory (pedsql)-multidimensional fatigue scale. evaluations will not be repeated after a certain interval.as a result of the comparison of both groups, it will be determined whether poms patients have difficulties or not.

Eligibility criteria:
inclusion criteria: * volunteer to participate * being diagnosed with pediatric onset multiple sclerosis * being between the ages of 15-22 * edss \<6 exclusion criteria: * having another diagnosis in addition to the diagnosis of pediatric-onset multiple sclerosis * having a blurred vision problem * having had an attack or received corticosteroid treatment 3 months before participating in the study

Keywords: pediatric-onset multiple sclerosis physiotherapy respiratory capacity fatigue
assessment of gastric ph changes induced by ascorbic acid tablets

Conditions: Hypochlorhydria

Summary: this study evaluates the use of ascorbic acid, vitamin c, to temporary reduce gastric ph in individuals with omeprazole induced hypochlorhydria. all participants will receive ascorbic acid tablets to measure the change in gastric ph.

elevation of gastric ph in patients with hypochlorhydria can reduce the solubility of weakly basic drugs. this may lead to poor and unpredictable systemic exposure for poorly soluble drugs. for example, extent of absorption of the kinase inhibitors, dasatinib (sprycel) and erlotinib (tarceva), is reduced by up to 61% and 46% respectively in patients on acid-reducing agents (aras). this pilot study is to evaluate the use of ascorbic acid, vitamin c, to temporary reduce gastric ph in individuals with omeprazole induced hypochlorhdyria. using ph/impedance testing, we are seeking to determine the magnitude and duration of ph change upon administration of 1000 mg of ascorbic acid in healthy subjects with proton-pump inhibitor induced hypochlorhydria. the results from this study will be used to evaluate the use of ascorbic acid as a drug-drug interaction mitigation strategy.

Eligibility criteria:
inclusion criteria: * healthy, young males age 18-30 years with no prior history of gastrointestinal disease or symptoms. exclusion criteria: * hypochlorhydria (baseline use antacids, antisecretory medications, or surface agents including proton-pump inhibitors, h2 blockers, or sucralfate). * current or previous history of gastrointestinal disease including gastroesophageal reflux disease, barrett's esophagus, peptic ulcer disease, dyspepsia, gastroparesis, bacterial overgrowth, microscopic colitis, gastric intestinal metaplasia or metaplastic atrophic gastritis, gastric neuroendocrine tumors, helicobacter pylori infection, inflammatory bowel disease (crohn's disease or ulcerative colitis), celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease). * history of gastric bypass or other abdominal surgeries excluding cholecystectomy or appendectomy \> 6 months prior to study initiation. * radiation therapy to the abdomen. * pregnant females. * ingestion of any prescription, over-the-counter, or herbal medications which may affect study interpretation. * currently a smoker * antibiotic use within the last 3 months
binaxnow for evaluating children for infection with sars-cov-2 (covid-19)

Conditions: SARS-CoV2 Infection; COVID-19

Summary: this is a study of the binaxnow covid-19 ag card as a method to rapidly identify sars-cov-2 infection in asymptomatic children, teachers, and other school staff for exclusion. 240 students and 80 teachers in the madison metropolitan school district (mmsd) will be enrolled and can expect to be on study for up to 8 weeks.

the overall purpose and research goal of this project is to understand how the virus sars-cov-2 is spread in the k-8 setting, decrease secondary cases of covid-19, improve attendance and educational opportunities for children, teachers and other school staff, and decrease time away from work for parents (with threat of loss of employment and other benefits). the investigators hypothesize that prompt diagnostic testing for sars-cov-2 in symptomatic children and twice weekly surveillance of asymptomatic children (with appropriate exclusion of children with positive tests) will be effective as a strategy to achieve maximum attendance in school and minimal disruption of the associated workforce. step 1: determine feasibility of using binaxnow covid-19 cards for surveillance of infection with sars-cov-2 in teachers, other school staff, and school children. the specific aims are to determine: * if it is feasible to obtain nasal samples to be used with the binaxnow covid-19 for diagnosis of covid-19 in children or teachers/other school staff. * if it is feasible to obtain nasal samples twice weekly to be used with binaxnow covid-19 for surveillance of infection with sars-cov-2. * the specificity of positive tests for sars-cov-2 obtained for diagnosis or surveillance compared to traditional pcr diagnostic testing. step 2: determine effectiveness of prompt diagnostic testing and twice weekly surveillance for sars-cov-2 among children and school faculty/staff to reduce the rate of positive cases (symptomatic) of covid-19 in an elementary school setting resulting in an ultimate decrease in absenteeism for students and an increase in attendance for their parents at the workplace. this is a record of the pilot study (step 1).

Eligibility criteria:
inclusion criteria: * children aged 5 - 15 years inclusive * currently attending school k-8 at one of the designated schools of the madison metropolitan school district * teachers and other school staff aged 20-65 years exclusion criteria: * children \ 16 years * teachers and other school staff \ 65 years

Keywords: diagnostic diagnosis schools binaxnow surveillance
the preliminary safety and efficacy of rrg001 after vitrectomy in subjects with proliferative diabetic retinopathy (pdr)

Conditions: PDR - Proliferative Diabetic Retinopathy

Summary: this study aims to slow down disease progression, reduce postoperative complications and decrease retreatment frequency in subjects with proliferative diabetic retinopathy (pdr) by administering a single subretinal injection of rrg001 gene therapy after vitrectomy.


Eligibility criteria:
inclusion criteria: * able and willing to provide informed consent * age \>= 20 years * diagnosis of diabetes mellitus (type 1 or type 2) * the study eye diagnosed with pdr, in the opinion of the investigator, requires vitrectomy and postoperative anti-vegf therapy, or that has undergone vitrectomy and still requires postoperative anti-vegf therapy * based on the etdrs chart, the best-corrected visual acuity (bcva) of the study eye is ≥ hand motion and ≤ 63 letters exclusion criteria: * active infection or inflammation in either eye * previous gene therapy in either eye * uncontrolled blood pressure（defined as systolic ≥160mmhg or diastolic ≥ 110mmhg by anti-hypertensive treatment) * hba1c \>12% for diabetes patients at screening * previous condition not eligible for study drug * history of major ocular surgery (except for pdr) or severe trauma * currently enrolled in another clinical trial or planning to enroll during the study * pregnant or lactating women * other conditions that, in the opinion of the investigator, would preclude participation in the study study eye-exclusion criteria： * ocular disorders that, in the opinion of the investigator, would confound the interpretation of study results or affect the administration * cnv or macular edema secondary to any causes other than diabetic retinopathy * ocular condition considered by the investigator to contraindicate subretinal injection * diagnosed primary or secondary glaucoma * history of intraocular corticosteroid treatment